KCT0001980进行中（未招募）未知
Randomised clinical trial comparing sequential and concomitant therapies for Helicobacter pylori eradication in routine clinical practice and changing of health insurance law
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 1,137
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1. Persons aged 19 and over
- •2. Patients who have undergone endoscopy within the last 3 months and who have been confirmed for Helicobacter pylori infection by biopsy or rapid urease test or urea breath test
- •3. Persons who agrees to participate in this study and who voluntarily signs the written consent
排除标准
- •1. Previous history of helicobacter pylori eradication
- •2. Those who had undergone previous gastrectomy (excluding endoscopic resection)
- •3. Screening results showed that patients with clinically significant abnormalities and those with liver function abnormalities (more than three times the normal upper limit of AST or ALT) or renal abnormalities (according to [Appendix 3] Case)
- •4. Those who have a history of allergy to the test drug
- •5. Proton pump inhibitor within 2 weeks before the start of the test drug or who took histamine receptor antagonist within 1 week after the start of the test drug
- •6. Those who have taken the following medicines within one week prior to the start of the study drug or who need to take it during the test period: aspirin (provided that aspirin 100 mg or less per day for prophylactic antithrombotic use is not acceptable ), Oral or intravenous steroids, NSAIDs, anticholinergics, prostaglandin analogs, pro-motility drugs, sucralfate)
- •7. Those who took antibiotics within 4 weeks before the start of the test drug
- •8. Pregnant women and lactating women, who are not fertile during pregnancy or who are not willing to use effective contraception during the test
- •9. Anyone who does not follow the scheduled visit schedule or fails the test procedure
- •10. Those who participated in other clinical trials within 3 months
- •11. Those who are taking one or more of the following drugs
- •(Lovastatin, Simvastatin, Atorvastatin, Indinavir, Ritonavir, Cyclosporin, Terfenadine, Cisapride, Pimozide, Astemizole, HIV protease inhibitors (Atazanavir, Nelfinavir), Ergot alkaloids and their derivatives(Ergotamine, Dihydroergotamine), Mizolastine, Bepridil, Ticagrelor)
- •12. Any person who is judged by the examiner to be in a condition that poses a health risk or interferes with the evaluation of the clinical trial subject
- •13. Those who have the following diseases : Patients with genetic problems such as infectious mononucleosis, central nervous system infected patients, patients with blood diseases or their history, patients with organic nervous system disease, galactosidosis and Lapp lactose dehydrogenase deficiency or glucose-galactose uptake disorders, patients with QT prolongation or ventricular arrhythmia (Including Torsades de pointes)
研究者
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